Hypervascularized Uterine Retentions Clinical Trial
— EMV RPOC AVMOfficial title:
Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study
| Verified date | November 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Background:
Hypervascularized products of conception remain a topic debated in terms of definitions
(ultrasound criteria, need complement by angio MRI) and management. The different uterine
vascular lesions are often confused. This is a recurrent problem and care are heterogeneous.
The aim of the study is to evaluate the management of these entities in CHU of Montpellier
and determine more homogeneous care. The investigators further aimed to evaluate clinical
presentation, ultrasound criteria, complications and the gynaecological and obstetrical
outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee.
The investigators will collect data from 64 individuals, aged 18 to 50, suffering from
uterine vascular lesions associated or not with products of conception between 2013 and 2019.
Caracterisitics of the population, ultrasound and angio MRI data will be collected.
Management wll be described as expectative, surgery or embolization of uterine arteries and
the success or not will be noted. The investigators will question patients on their
gynaecologic and obstetrical outcomes by telephone.
•Discussion: The investigators aim to define and characterize the different lesions,
establish ultrasound criteria that would guide treatments. Describe the current treatments
and compare them in terms of efficiency and safety in order to establish a homogeneous
treatment protocol in our center
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | November 1, 2019 |
| Est. primary completion date | October 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion criteria: - Women - Aged between 18 and 50 years - Managed in CHU Montpellier - Diagnosis of hypervascularized products of conception - Available ultrasound pictures Exclusion criteria: - Subject unable to understand the study - Subject with another diagnosis of bleeding - Subject who have retained products of conception with no vascularity or immediate curettage with uterine vacuity - Subject who have no available ultrasound pictures |
| Country | Name | City | State |
|---|---|---|---|
| France | Uh Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of the effects of the selected design products Evolution of the effects of the selected design products | the incidence of retained products of conception associated with enhanced myometrial vascularity | 1 day | |
| Primary | ultrasound vascularity assessment | ultrasound vascularity assessment for predicting future severe hemorrhage in retained products of conception with comparison of doppler color score (scale of the author Akiba, Kamaya and the Doppler color scoring system) | 1 day | |
| Primary | compare managing of these entities | compare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety | 1 day | |
| Secondary | assessment of the women quality of life | assessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey | 1 day |